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Bayer Issues Voluntary Recall Nationwide of VITRAKVI® (larotrectinib) Oral Solution 20 mg/mL Due to Presence of Microbial Contamination

Bayer is voluntarily recalling one lot of Vitrakvi® (larotrectinib) Oral Solution 20 mg/mL in 100mL glass bottles to the consumer/user level. The product is being recalled due to microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing.
Carolyn Nagle Bayer Medical Information Call Center Company Contact Information Company Announcement Company Name Drug Administration
Source: fda.gov

Kye Pharmaceuticals partners with Hyloris Pharmaceuticals for the Development and Commercialization of Atomoxetine Oral Solution in Canada

Kye Pharmaceuticals Inc. ("Kye"), a Canadian specialty pharmaceutical company, announced its partnership with Hyloris Pharmaceuticals SA ("Hyloris"), a Belgium-based developer, manufacturer and global supplier of a novel, prescription, oral solution form of atomoxetine. Through this partnership, Kye becomes the exclusive Canadian rights holder for the Atomoxetine Oral Solution developed by Hyloris. Under the terms of the agreement, Kye is responsible for the registration and ...
Stijn Van Rompay John Mckendry Hyloris Pharmaceuticals Skye Pharmaceuticals Pharmaceuticals Inc Atomoxetine Oral Solution
Source: yahoo.com

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Lupin : October 13, 2023 Lupin Receives Tentative Approval from U.S. FDA for Calcium, Magnesium, Potassium, and Sodium Oxybates Oral Solution -October 13, 2023 at 02:04 am EDT

Mumbai, Baltimore, October 12, 2023: Global pharma major Lupin Limited today announced that it has received tentative approval from the United States Food and Drug Administration for...
United States South Africa Shweta Munjal Asia Pacific Drug Administration Jazz Pharmaceuticals Ireland

Novartis Issues Voluntary Nationwide Recall of One Lot of Sandimmune® Oral Solution (Cyclosporine Oral Solution, USP), 100 mg/mL Due to Crystallization

Novartis is conducting a voluntary nationwide recall at the consumer level of one lot of its Sandimmune® Oral Solution (cyclosporine oral solution, USP), 100 mg/mL in the US due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. No other Sandimmune for
United States Julie Masow Sloan Simpson Michael Meo Marlena Abdinoor Company Announcement
Source: fda.gov

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